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What is in this leaflet

This leaflet answers some common questions about Mirtazon. It does not contain all
the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Mirtazon against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Mirtazon is used for

Mirtazon is used in the treatment of depression including relapse prevention.

Depression is longer lasting or more severe than "low moods" everyone has from time
to time due to the stress of everyday life. It is thought to be caused by a chemical
imbalance in parts of the brain. This affects your whole body and can cause emotional
and physical symptoms such as feeling low in spirit, loss of interest in activities,
unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up
early, loss of sex drive, lack of energy and feeling guilty over nothing.

This medicine corrects this chemical imbalance and may help relieve the symptoms of
depression.

Your doctor, however, may prescribe it for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

This medicine is only available with a doctor's prescription.

Mirtazon is not addictive.

Before you take Mirtazon

When you must not take it

Do not take Mirtazon:

if you are allergic to medicines containing mirtazapine

if you are allergic to any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives,
swelling of the face, lips, mouth, throat or other parts of the body, shortness of
breath, wheezing or trouble breathing.

Do not take Mirtazon if you are taking another medicine for depression called a monoamine
oxidase inhibitor (MAOI) or have been taking an MAOI within the last 14 days. If
you stop taking Mirtazon, do not take MAOI during the next two weeks either.

Taking Mirtazon with an MAOI may cause a serious reaction with a sudden increase in
body temperature, extremely high blood pressure and severe convulsions.

Examples of this type of medicine include phenelzine, tranylcypromine and selegiline.

Ask your doctor or pharmacist if you are not sure if you are or if you have been taking
a MAOI medicine.

Do not take Mirtazon if the packaging is torn or shows signs of tampering.

Do not take Mirtazon if the expiry date printed on the pack has passed.

If you are not sure whether you should start taking Mirtazon, talk to your doctor.

Before you start to take it

Do not give Mirtazon to a child or adolescent.

The safety of Mirtazon in patients under 18 years has not been established.

Tell your doctor if:

1. you are allergic to any other medicines, foods, dyes or preservatives

2. you are pregnant or plan to become pregnant.

Like most medicines of this kind, Mirtazon is not recommended to be used during pregnancy.
Your doctor will discuss the risks and benefits of taking Mirtazon when pregnant.

3. you are breastfeeding or wish to breastfeed.

It is not known whether Mirtazon passes into breast milk.

4. if you have or have had any medical conditions, especially the following:

thoughts of suicide or self-harm

epilepsy (fits or convulsions)

liver disease such as jaundice

kidney disease

heart disease

low blood pressure

certain kinds of heart conditions that may change your heart rhythm, a recent heart
attack, heart failure, or take certain medicines that may affect the heart's rhythm.

any mental illness (e.g. schizophrenia, manic depression)

diabetes

glaucoma (increased pressure in the eye)

problems in urinating due to an enlarged prostate

unexplainable high fever, sore throat and mouth ulcers

galactose intolerance

glucose-galactose malabsorption

If you have not told your doctor about any of the above, tell them before you take
Mirtazon.

Tell your doctor if you react badly to lactose or milk before you start taking Mirtazon.

Mirtazon tablets contain lactose.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy
without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by Mirtazon or may affect how well it works. These
include:

benzodiazepines, medicines used to treat anxiety and sleeping problems

lithium, a medicine used to treat some psychiatric conditions

methylene blue (used to treat high levels of methemoglobin in the blood)

tramadol, a pain killer

morphine, a medicine for severe pain

cetirizine, a medicine for allergies

warfarin, a medicine used to prevent blood clotting

linezolid or erythromycin, both antibiotics

rifampicin, a medicine used to treat tuberculosis

medicines used to treat fungal infections such as ketoconazole

HIV/AIDS medications

cimetidine, a medicine used to treat reflux and stomach ulcers

triptans such as sumatriptan, naratriptan and zolmitriptan, medicines used to treat
migraine

medicines that may affect the heart's rhythm such as certain antibiotics and some
anti-psychotics.

Your doctor will tell you what to do if you are taking any of these medicines.

Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while taking Mirtazon

If you are not sure whether you are taking any of these medicines, check with your
doctor or pharmacist.

How to take Mirtazon

Follow all directions given to you by your doctor and pharmacist.

They may differ from the information contained in this leaflet.

How much to take

Your doctor will tell you how much Mirtazon to take each day. Take exactly the amount
your doctor tells you.

The usual starting dose is 15mg per day. Your doctor may slowly increase this dose
depending on how you respond to Mirtazon. The effective dose for most people is usually
between 30mg and 45mg per day.

Your doctor may have prescribed a different dose.

If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.

When to take it

Take Mirtazon at about the same time each day.

Your doctor will tell you when to take your tablets.

The tablet(s) should be taken at the same time each day, preferably as a single night-time
dose before going to bed; if recommended by your doctor, Mirtazon may be taken in
sub-doses equally divided over the day (once in the morning and once at night-time
before going to bed).

How to take it

Swallow the tablet(s), without chewing, together with some water or other fluid.

How long to take it

Keep taking Mirtazon until your doctor tells you to stop.

For depression, the length of treatment will depend on how quickly your symptoms improve.
Most antidepressants take time to work, so do not be discouraged if you don't feel
better right away. Some of your symptoms may improve in 1 to 2 weeks but it can take
up to 2 - 4 weeks to feel the full benefit of the medicine.

Even when you feel well, you will usually have to take Mirtazon for 4 to 6 months
or even longer to make sure the benefits will last.

If you forget to take it

ONCE DAILY DOSING

If you forget to take the tablet before you go to bed, do not take the missed dose
next morning. It may cause drowsiness or sleepiness during the day. Continue treatment
in the evening with your normal dose.

TWICE DAILY DOSING

Morning dose forgotten - simply take it together with your evening dose.

Evening dose forgotten - do not take it with the next morning dose. Continue treatment
with your normal morning and evening doses.

Both doses forgotten - do not try to make up for the missed tablets. Continue with
your usual morning and evening dose the next day.

If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia
13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if
you think you or anyone else may have taken too much Mirtazon. Do this even if there
are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too many Mirtazon tablets, you may feel drowsy, dizzy, confused, and agitated.

You may also have changes to your heart rhythm (fast, irregular heartbeat) and/or
fainting which could be symptoms of a life-threatening condition known as Torsade
de Pointes.

While you are taking Mirtazon

Things you must do

Tell your doctor immediately if you develop fever, chills, sore throat or mouth ulcers
or other signs of frequent infections. Stop taking Mirtazon and consult with your
doctor for a blood test.

In rare cases mirtazapine can cause disturbances in the production of blood cells
(bone marrow depression). Some people become less resistant to infection because Mirtazon
can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases
Mirtazon can also cause a shortage of red and white blood cells, as well as blood
platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an
increase in the number of white blood cells (eosinophilia). While rare, these symptoms
most commonly appear after 4-6 weeks of treatment.

Tell your doctor immediately or go to the nearest hospital for treatment if you have
any suicidal thoughts or other mental/mood changes.

Occasionally, the symptoms of depression or other psychiatric conditions may include
thoughts of harming yourself or committing suicide. Until the full antidepressant
effect of your medicine becomes apparent, it is possible these symptoms may increase
in the first few weeks of treatment.

Information from clinical trials have shown an increased risk of suicidal behaviour
in young adults aged less than 25 years with psychiatric conditions who were treated
with an antidepressant.

If you or someone you know is showing warning signs of suicide-related behaviour while
taking Mirtazon, contact your doctor or a mental health professional right away or
go to the nearest hospital for treatment. These signs include:

thoughts or talk about death or suicide

thoughts or talk of self-harm or harm to others

any recent attempts of self-harm

increase in aggressive behaviour, irritability or agitation.

All mentions of suicide or violence must be taken seriously.

You may find it helpful to tell a relative or close friend that you are depressed,
and ask them to read this leaflet. You might ask them to tell you if they think your
depression is getting worse, or if they are worried about changes in your behaviour.

Tell your doctor if you become pregnant while taking this medicine. Do not stop taking
your tablets until you have spoken to your doctor.

If you use Mirtazon until, or shortly before birth, your baby should be supervised
for possible adverse effects.

Ask your doctor whether you can breast-feed, while taking Mirtazon.

Tell your doctor if for any reason you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment
unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can
be checked.

You may need to have blood tests from time to time.

Before starting any new medicine, tell your doctor or pharmacist that you are taking
Mirtazon.

Tell all doctors, dentists and pharmacists who are treating you that you are taking
Mirtazon.

Things you must not do

Do not drive or operate machinery until you know how Mirtazon affects you.

Mirtazon may cause drowsiness, dizziness or sleepiness in some people and affect alertness
and concentration. If any of these occur, do not drive, operate machinery or do anything
else that could be dangerous.

Do not suddenly stop taking Mirtazon, or lower the dose, without first checking with
your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not stop taking Mirtazon, even if you feel better, unless advised by your doctor.

Your doctor may want to gradually reduce the amount of Mirtazon you are taking before
stopping completely.

Do not use Mirtazon to treat any other conditions unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours
or if they have the same condition as you.

Things to be careful of

You are advised not to drink any alcohol while taking Mirtazon.

Combining Mirtazon and alcohol can make you more sleepy and less alert. Your doctor
may suggest you avoid alcohol while being treated with this medicine.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Mirtazon.

Mirtazon helps most people with depression, but it may have unwanted side effects
in a few people. All medicines can have side effects. Sometimes they are serious,
most of the time they are not. You may need medical treatment if you get some of the
side effects.

Ask your doctor or pharmacist any questions you may have.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor if you notice any of the following and they bother you:

lethargy, drowsiness or sleepiness

headache

tiredness

increase in appetite and weight gain

dry mouth

nausea, vomiting

diarrhoea

constipation

dizziness

dizziness or faintness when getting up quickly from a lying or sitting position (low
blood pressure)

abnormal sensations in the mouth sensations of numbness in the mouth or swelling
in the mouth

aggression

swollen ankles or feet as a result of fluid accumulation (oedema)

rash or skin eruptions

nightmares/vivid dreams

tingling fingers or toes

painful joints

back pain

muscle aches and pains

restless legs

abnormal sensation in the skin for example burning, stinging, tickling or tingling

urge to move

difficulty in passing urine (urinary retention)

speech disorders

anxiety, insomnia. These may be symptoms of depression

Tell your doctor immediately, or go to the Accident and Emergency at your nearest
hospital if you notice any of the following:

suicidal ideation or behaviour

epileptic attack (seizures)

shaking or tremors

sudden muscle contractions (myoclonus)

attack of excessive excitability (mania)

agitation

confusion

hallucinations

changes to your heart rhythm

fainting

yellow colouring of eyes or skin; this may suggest disturbance in liver function

abdominal pain and nausea; this may suggest inflammation of the pancreas

generalised fluid retention with weight gain

skin rash, itching or hives; swelling of the face, lips or tongue which may cause
difficulty breathing

signs of infection such as sudden unexplainable high fever, sore throat and mouth
ulcers

Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice anything else that is making you feel unwell.

Ask your doctor or pharmacist if you don't understand anything in this list.

After taking Mirtazon

Storage

Keep your tablets in their blister pack until it is time to take them.

The tablets may not keep as well if you take them out of the blister pack.

Store below 30°C in a dark, dry place.

Do not store Mirtazon, or any other medicine, in a bathroom or near a sink. Do not
leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep this medicine where young children cannot reach it.

A locked cupboard at least one-and-a half metres above the ground is a good place
to store medicines.

Disposal

Return any unused medicine to your pharmacist.

Medicines should not be disposed of via waste water or household waste.

Product Description

What it looks like

Mirtazon is available in two strengths: 30mg and 45mg.

The 30 mg tablets are red-brown; one side of the tablet is marked with "Organon" or
"MSD", the other with the code "TZ" and "5" on both sides of the score. The tablets
have a single breakline, which means that they can easily be divided in two if necessary.

The 45 mg tablets are white; one side of the tablet is marked with "Organon", the
other with the code "TZ" and "7". There is no score line.